Caregiver Training for Brachial Plexus Injury

(CTP-BPBI Trial)

Recruiting at 1 trial location

Overseen By Jennifer Wingrat, ScD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Disqualifiers: Infant older than 6 months, Non-BPBI diagnosis, Surgery before 9 months, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how training methods can help caregivers better perform PROM (passive range of motion exercises) for infants with brachial plexus birth injury (BPBI). The goal is to determine if improved training boosts caregiver confidence and consistency in performing these exercises, potentially reducing the risk of shoulder contractures (tightening of muscles and tendons). One group will receive detailed training with visual aids and checklists, while the other will receive standard instructions. Caregivers of infants younger than 6 months with BPBI are suitable candidates for this trial. As an unphased trial, this study offers caregivers the chance to enhance their skills and potentially improve outcomes for their infants.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this training protocol is safe for caregivers and infants?

Research has shown that training caregivers to perform gentle exercises on infants with brachial plexus birth injury (BPBI) is generally safe. In a small study, caregivers who learned these exercises regularly helped prevent shoulder stiffness in infants. Simple pictures and videos ensured caregivers felt confident and performed the exercises correctly.

Safety reports from similar studies have shown no major side effects when these exercises are done properly. This indicates that the training methods being tested are well-received. Designed to boost caregivers' skills and confidence, the training aims to be both effective and safe for infants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on enhancing how caregivers can support infants with brachial plexus injuries through specialized training techniques. The trial introduces a novel approach by using a visual handout and video recordings paired with a detailed step-by-step checklist for shoulder stretches. This method aims to improve the accuracy and effectiveness of caregivers performing passive range of motion (PROM) exercises at home. By refining caregiver training, the trial hopes to achieve better outcomes for infants, potentially advancing the standard of care beyond basic instructional handouts.

What evidence suggests that this training protocol is effective for improving caregiver adherence to PROM for infants with brachial plexus injury?

Research has shown that gentle, passive exercises with an infant's arm can benefit babies with brachial plexus birth injury (BPBI). A small study reviewed cases and found that babies who received these exercises twice daily were less likely to develop shoulder stiffness, which can hinder movement. Caregivers must feel confident and perform these exercises regularly for optimal effectiveness. Clinical observations also indicate that frequent exercises can prevent stiffness. This trial will compare two training protocols for caregivers. Group A will receive a pilot training protocol with supplemental materials and feedback, while Group B will follow a standard protocol. Improved training for caregivers may help them adhere to the exercise routine, potentially reducing the risk of long-term arm problems in babies with BPBI. ^{3 6 7 8 9}

Who Is on the Research Team?

Matthew Elrick, MD, PhD

Principal Investigator

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Are You a Good Fit for This Trial?

This trial is for caregivers aged 18 or older of infants under 6 months with a confirmed brachial plexus birth injury (BPBI), as determined by a specialized clinic team. The study aims to help these caregivers perform daily arm stretching exercises on their infants.

Inclusion Criteria

I am over 18 and care for an infant under 6 months with a confirmed brachial plexus injury.

Exclusion Criteria

I am caring for a baby over 6 months old with an upcoming brachial clinic appointment.

I am caring for an infant needing surgery for BPBI before 9 months old.

I care for an infant with a condition affecting their arm nerves, not due to birth injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Training

Caregivers receive training in PROM techniques, including visual handouts, video recordings, and a step-by-step checklist for Group A

1 day

1 visit (in-person)

Follow-up

Caregivers are observed performing PROM and their efficacy and self-confidence are assessed

1-6 months

1 visit (in-person)

Long-term Monitoring

Participants are monitored for adherence to PROM and development of shoulder contractures

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Pilot Training Protocol

Trial Overview The trial tests two training methods for caregivers: a new 'Pilot Training Protocol' and the existing 'Standard Training Protocol'. It will compare how well each method helps caregivers in performing passive range of motion exercises, improving their confidence, and adhering to daily routines.

How Is the Trial Designed?

Group I: Group A - Pilot Protocol Experimental Treatment 1 Intervention

Participants in Group A will receive training in PROM techniques via a visual handout with pictures and written instructions and video recording using the caregiver's cell phone/tablet of the trainer and/or caregiver performing PROM on the infant. Participants in Group A will also receive supplemental training including a step-by-step checklist for each of the shoulder stretches that are recommended and will be instructed to refer to the checklist each time they perform PROM at home. Participants will be observed performing PROM at their initial visit where training occurs and at their infants' next follow-up visit. The standardized checklist will be used to assess efficacy of caregivers' demonstrated PROM including assessment of positioning, hand placement, and number of cues needed to facilitate accuracy; specific feedback will be given as needed.

Group II: Group B - Standard Protocol Active Control 1 Intervention

Participants in Group B will receive training in PROM techniques via the same visual handout with pictures and written instructions provided to Group A as well as video recording using the caregiver's cell phone/tablet of the trainer and/or caregiver performing PROM on the infant.

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials

93

Recruited

25,200+

Towson University

Collaborator

Trials

10

Recruited

520+

Published Research Related to This Trial

A study involving 51 participants (21 adults with brachial plexus injury and 30 expert clinicians) identified 522 activities that are limited due to traumatic brachial plexus injury, highlighting the extensive impact on daily life.

The findings revealed that many of these activities are not adequately captured by existing patient-reported outcome measures, suggesting a need for a new questionnaire specifically designed for brachial plexus injury to better assess patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do existing patient-report activity outcome measures accurately reflect day-to-day arm use following adult traumatic brachial plexus injury? Hill, B., Williams, G., Olver, JH., et al.[2019]

The Thai version of the KKU-DASH questionnaire demonstrated good to excellent internal consistency across its domains, indicating it is a reliable tool for assessing disability in patients with brachial plexus injuries.

The KKU-DASH showed strong convergent validity with the SF-36 health survey, particularly in the social activity domain, confirming its effectiveness in measuring the impact of brachial plexus injuries on patients' quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of the Thai version of Disability of the Arm, Shoulder and Hand Questionnaire (KKU-DASH) in patients with brachial plexus injury. Jianmongkol, S., Kosuwon, W., Thammaroj, T., et al.[2022]

Families with children suffering from brachial plexus injuries (BPIs) reported a significant overall family impact score of 43 out of 100, indicating substantial personal and financial strain.

The study, which included 102 caregivers, highlighted that the financial burden and the need for national travel for treatment were major contributors to the family's perceived impact, suggesting a need for multidisciplinary support to address these challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of pediatric brachial plexus injury on families. Louden, E., Allgier, A., Overton, M., et al.[2022]

A systematic review of 138 studies on traumatic brachial plexus injury (TBPI) identified 1491 outcomes, revealing a significant focus on musculoskeletal impairments, with 86% of studies measuring these outcomes.

The review highlighted a lack of standardization in outcome reporting, with over two-thirds of outcomes reported incompletely, suggesting the need for a core outcome set to improve consistency and relevance in future TBPI research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a core outcome set for traumatic brachial plexus injuries: a systematic review of outcomes. Miller, C., Cross, J., O'Sullivan, J., et al.[2022]

The journey guide, an educational tool created for patients with traumatic brachial plexus injury (BPI), received a high satisfaction score of 8.4 out of 10, indicating it effectively addresses patient education needs and improves understanding of their condition.

Qualitative feedback from 19 participants highlighted that the guide is particularly useful immediately after injury and serves as an effective organizational tool, although suggestions for improvement included enhancing visual elements and fostering community engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Assessment of a Patient "Journey Guide" for Adult Traumatic Brachial Plexus Injury. Navarro, B., Liebendorfer, A., Voorhees, M., et al.[2023]

The Brachial Assessment Tool (BrAT) has shown to be a valid and responsive measure for assessing outcomes in adults with traumatic brachial plexus injury, demonstrating a strong correlation with the Upper Extremity Functional Index (UEFI) and the ability to distinguish between varying levels of hand use.

Preliminary results suggest that the BrAT is more targeted for individuals with severe injuries compared to the Disabilities of the Arm, Shoulder and Hand (DASH) and UEFI, indicating it may measure different aspects of activity related to brachial plexus injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Psychometric Evaluation of the Brachial Assessment Tool Part 2: Construct Validity and Responsiveness. Hill, B., Williams, G., Olver, J., et al.[2019]

Patients with traumatic brachial plexus injury (n=36) have similar levels of social support compared to healthy volunteers (n=43), indicating that emotional and social support may not differ significantly between these groups.

However, these patients tend to use a wider range of coping strategies, including some potentially harmful ones like self-blame and denial, which could negatively impact their recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Social Support and Coping Strategies in Patients with Traumatic Brachial Plexus Injury. Sachar, R., Landau, AJ., Ray, WZ., et al.[2022]

Brachial plexus birth injury can lead to upper-limb paralysis in children, with 10% to 30% experiencing lasting neurological deficits that affect their arm function.

Early intervention with occupational therapy focusing on range of motion and motor learning is crucial, and surgical reconstruction of the brachial plexus may be necessary for some children, typically performed between 3 to 9 months of age.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team Approach: Management of Brachial Plexus Birth Injury. Schmieg, S., Nguyen, JC., Pehnke, M., et al.[2021]

Citations

1. trials.arthritis.org trials.arthritis.org/trials/NCT06623357

Pilot Test of Caregiver Training Protocol for Brachial Plexus ... The standardized checklist will be used to assess the efficacy of caregivers' demonstrated PROM which includes assessment of positioning, hand placement, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10150106/

Review of rehabilitation protocols for brachial plexus injury The purpose of this article is to explore the potential contributions of various methods to brachial plexus injury rehabilitation and to provide a concise ...

3. mdpi.com mdpi.com/2077-0383/13/20/6186

Systematic Review and Meta-Analysis of Intervention ... The objective of this paper is to analyze the therapeutic intervention techniques used at an early stage and their functional impact.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0894113019300985

Outcomes after occupational therapy intervention for ... Occupational therapy with surgical intervention can improve strength, range, and upper limb function with people following traumatic BPI.

5. researchprotocols.org researchprotocols.org/2023/1/e46054/

Efficacy of Naprapathy in Brachial Plexus Injury Sample Size. Our previous study indicated that 58.5% of patients with BPI showed improvements in upper extremity function and muscle strength [ ...

6. withpower.com withpower.com/trial/caregiver-training-for-brachial-plexus-injury-defa1

Caregiver Training for Brachial Plexus Injury (CTP-BPBI Trial) A systematic review of 138 studies on traumatic brachial plexus injury (TBPI) identified 1491 outcomes, revealing a significant focus on musculoskeletal ...

7. trialstoday.org trialstoday.org/trial/NCT06623357

Pilot Test of Caregiver Training Protocol for Brachial Plexus ... ... data on a caregiver training protocol for PROM for infants with BPBI. Study duration will be up to three years with rolling enrollment of ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S097432272400526X

Safety and efficacy of outpatient versus inpatient adult ... This study demonstrates that outpatient brachial plexus surgery is a safe option for properly selected patients. Procedures were more often performed outpatient ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10895927/

Frequency, Facilitators, and Barriers for Range of Motion to ... This pilot study investigated the efficacy of passive range of motion (PROM) during the first year of life to prevent development of shoulder contractures.